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Local Trust Management Approval or Confirmation of Capacity and Capability and Ongoing Study Oversight

Researchers should contact the R&D office as soon as possible when they become aware that they may be participating in a research study or clinical trial.

In order to confirm capacity and capability to participate in the research, the R&D office will require copies of all study documentation. The information provided enables the Trust to assess the impact of the study on the organisation - feasibility, capability, research costs and general level of risk.

Additionally the study team should provide approval from the following organisations.

IRMER Practitioner / Medical Physics

For studies using ionising radiation, where OUH is not the lead site (and therefore the signatures on the R&D form are not from OUH) the signature of the local Radiation Protection Officer and IRMER Practitioner for the site where the research is taking place must be obtained. For studies involving histopathology you will need to supply evidence that they have reviewed the study.

If your proposed study has any commercial involvement; involves a third party; is multicentre; or is a clinical trial you may need to have a contract/agreement in place. It is essential that, whenever possible, standard DOH templates are used. This will considerably reduce the time needed to review these.

OUH Trust Management Approval cannot be given until all other relevant regulatory or other approvals (e.g. HRA, REC, MHRA, and NIGB) are in place. If your study involves a contract or agreement, this will also need to be fully executed before we can release your approval letter.

Recruitment must not begin until all approvals are in place because the study would not be indemnified by the Trust.

To maintain ongoing Trust Management Approval it is necessary to provide the R&D Department with copies of Annual Progress Reports and if applicable, Annual Safety Reports.

University Hosted Studies (non-NHS SSI form)

For studies carried out on University premises, a non-NHS SSI form may be required. All Site Specific Assessments (SSAs) for non-NHS sites are now undertaken by the main REC carrying out the ethical review of the research ethics application.

Feasibility Review for IRAS Top Four Category Research

If your proposed research at OUH is in one of the following four categories, before you apply for Trust approval you need to contact the R&D Team to undergo a feasibility review.

Clinical trial of an investigational medicinal product

Clinical investigation or other study of a medical device

Combined trial of an investigational medicinal product and an investigational medical device

Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice

Feasibility review is part of a larger project management focused overview that R&D will help ensure that both the first patient to a trial is recruited within the NIHR target of 70 days, and that the trial recruits all contracted participants by the target date wherever possible.

Topics to be considered

Disease area and number of potential participants seen in OUH clinics against inclusion and exclusion criteria in the proposed protocol and the target suggested by the sponsor?

Other competing research?

Approvals by steering groups and management team?

Capacity of clinical area and team - are all staff already in post?

Will the proposal fit with the current care pathway for patients?

Service support department involvement and capacity?

Costing and agreement to fund by spondor?

Contractural framework for research?

Is there a site initiation visit already booked?

Only once the feasibility has been received and approved, on behalf of the Director of R&D can the proposal proceed to SSI submission.

Research Tissue Banks / Research Data Banks

Research Tissue and Data Banks are not included in the HRA approval process and any researcher wishing to take part in either of these will be required to apply to the OUH R&D office for Trust Management Approval.

OUH requires that all Research Tissue Bank (Biobank) and Research Data Bank (Database) applications be submitted to an NHS REC for ethical review.

Research proposal documents must be sent to the R&D Team for review before submission to a REC and/or the Human Tissue Authority (HTA).

For full details, please refer to our Research Tissue Banks / Research Data Banks page.

Local ApprovalsFor studies using ionising radiation, where OUH is not the lead site (and therefore the signatures on the R&D form are not from OUH) the signature of the local Radiation Protection Officer and IRMER Practitioner for the site where the research is taking place must be obtained.

For studies involving histopathology you will need to supply evidence that they have reviewed the study.

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Evidence of Independent Scientific Review
Details of acceptable forms of peer review are available on this website: